Approval for revised labeling based on the findings of the post-approval study for the spf(r) implantable bone growth stimulator.
| Device | SPF IMPLANTABLE BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 2000-03-31 |
| Decision Date | 2000-09-27 |
| PMA | P850035 |
| Supplement | S025 |
| Product Code | LOE |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850035 | | Original Filing |
| S058 |
2022-10-28 |
30-day Notice |
| S057 |
2022-05-27 |
Real-time Process |
| S056 |
2021-01-21 |
30-day Notice |
| S055 |
2019-06-21 |
30-day Notice |
| S054 | | |
| S053 |
2018-04-09 |
30-day Notice |
| S052 |
2018-04-04 |
30-day Notice |
| S051 |
2018-04-02 |
135 Review Track For 30-day Notice |
| S050 |
2018-03-29 |
30-day Notice |
| S049 |
2018-03-09 |
30-day Notice |
| S048 |
2018-03-01 |
30-day Notice |
| S047 |
2018-02-21 |
30-day Notice |
| S046 |
2018-02-13 |
30-day Notice |
| S045 |
2017-05-04 |
30-day Notice |
| S044 |
2017-03-14 |
30-day Notice |
| S043 |
2016-10-31 |
Special (immediate Track) |
| S042 |
2016-02-19 |
Special (immediate Track) |
| S041 |
2015-12-17 |
30-day Notice |
| S040 |
2015-11-19 |
30-day Notice |
| S039 |
2015-10-08 |
30-day Notice |
| S038 |
2014-08-20 |
30-day Notice |
| S037 | | |
| S036 |
2013-09-06 |
30-day Notice |
| S035 |
2013-04-30 |
30-day Notice |
| S034 |
2012-02-01 |
30-day Notice |
| S033 |
2008-07-22 |
Normal 180 Day Track No User Fee |
| S032 |
2008-07-17 |
30-day Notice |
| S031 |
2007-02-23 |
Real-time Process |
| S030 |
2004-06-09 |
Normal 180 Day Track |
| S029 |
2002-06-13 |
Normal 180 Day Track |
| S028 |
2000-05-30 |
Real-time Process |
| S027 | | |
| S026 | | |
| S025 |
2000-03-31 |
Normal 180 Day Track |
| S024 |
1998-07-06 |
Normal 180 Day Track |
| S023 |
1998-04-09 |
Real-time Process |
| S022 |
1997-04-08 |
Real-time Process |
| S021 |
1996-10-17 |
Normal 180 Day Track |
| S020 |
1996-07-19 |
Normal 180 Day Track |
| S019 |
1996-03-13 |
Normal 180 Day Track |
| S018 |
1995-12-08 |
Special (immediate Track) |
| S017 |
1994-11-22 |
Normal 180 Day Track |
| S016 |
1994-11-15 |
Normal 180 Day Track |
| S015 | | |
| S014 | | |
| S013 |
1992-03-27 |
Normal 180 Day Track |
| S012 |
1991-05-10 |
Normal 180 Day Track |
| S011 | | |
| S010 |
1990-10-25 |
Normal 180 Day Track |
| S009 | | |
| S008 |
1990-05-31 |
Normal 180 Day Track |
| S007 |
1988-12-16 |
Normal 180 Day Track |
| S006 |
1988-10-12 |
Normal 180 Day Track |
| S005 |
1988-04-18 |
Normal 180 Day Track |
| S004 |
1988-03-16 |
Normal 180 Day Track |
| S003 |
1988-02-26 |
Normal 180 Day Track |
| S002 |
1988-01-15 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices